Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 208

Results For "FDA"

2194 News Found

PCI Pharma Services acquires LSNE for its CDMO business
News | October 13, 2021

PCI Pharma Services acquires LSNE for its CDMO business

Transformational partnership establishes PCI as a CDMO and broadens capabilities across drug product lifecycle


Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis
Biotech | October 09, 2021

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis

The rolling submission to the U.S. FDA will begin in the fourth quarter of this year


Tezepelumab granted Orphan Drug Designation in the US
Biotech | October 09, 2021

Tezepelumab granted Orphan Drug Designation in the US

Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)


Gland Pharma receives tentative nod for Sugammadex injection
Drug Approval | October 09, 2021

Gland Pharma receives tentative nod for Sugammadex injection

The injection is used to reverse the effects of the muscle relaxants given to patients during surgery


Lincoln Pharma gets Australian TGA approval
News | October 08, 2021

Lincoln Pharma gets Australian TGA approval

The company plans to expand its portfolio in regulated markets aggressively


Lupin receives tentative approval for Brexpiprazole tablets
Drug Approval | October 06, 2021

Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India


AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)


DentalMonitoring launches ScanBox, an AI-powered orthodontic care device
Medical Device | October 05, 2021

DentalMonitoring launches ScanBox, an AI-powered orthodontic care device

DentalMonitoring, the company that pioneered artificial intelligence in dental and orthodontic care, has announced the launch of the ScanBox


Amber Implants VCFix spinal system receives breakthrough designation
Healthcare | October 05, 2021

Amber Implants VCFix spinal system receives breakthrough designation

The first clinical trial is expected to commence in early 2022 both in Europe and the US


ResMed acquires home sleep testing company Ectosense
Startup | October 05, 2021

ResMed acquires home sleep testing company Ectosense

Ectosense’s NightOwl is a leading cloud-connected home sleep apnea test